EFFICACY OF SUBCUTANEOUS SUMATRIPTAN IN THE ACUTE TREATMENT OF EARLY-MORNING MIGRAINE - A PLACEBO-CONTROLLED TRIAL

Objectives. To evaluate the efficacy of self-administered subcutaneous sumatriptan in the acute treatment of early-morning migraine attacks. Design. A double-blind, randomized, placebo-controlled, cross-over st udy. Setting. Thirteen neurology centres in France. Subjects. Patients of either sex, 18-65 years old, with two to six attacks of migraine ( according to the International Headache Society (IHS) criteria, with o r without aura) per month, of which at least two had to be early-morni ng migraine attacks. One-hundred-and-one patients were included, 96 be ing evaluable for the first attack and 81 for the cross-over design. I nterventions. Two migraine attacks (grade 2/3) were treated with sumat riptan (6 mg) or placebo, with an optional second injection 1-24 h lat er. Main outcome measures. The primary end-point was headache relief: reduction in headache severity from grade 2/3 (moderate/severe) to gra de 1/0 (mild/none) 2 h after treatment. Results. Sumatriptan was super ior to placebo for headache relief (32 [78%] vs. 11 [28%] at the first attack; 2 9 [ 73%] vs. 8 [20%] at the second; P < 0.001). Because of a significant carry-over effect for some of the secondary end-points, a parallel-group analysis of the first attack was performed, which con firmed a significantly higher efficacy of sumatriptan for all end-poin ts: pain-free rate (22 [46%] vs. 7 [15%]; P = 0.001) and use of a seco nd injection (26 [53%] vs. 38 [81%]; P = 0.004). Sumatriptan was prefe rred by 74% of patients vs. 1 7% for placebo, and 9 % expressed no pre ference (P < 0.000 1). After complete relief, headache reappeared in 8 /2 3 (3 5%) patients with sumatriptan and 3/7 (43%) with placebo. Adve rse events were significantly more frequent with sumatriptan but they were minor and transient. Conclusion. Subcutaneous sumatriptan auto-in jection is an effective and well-tolerated acute treatment of early-mo rning migraine attacks allowing earlier return to normal activity.